Royal Derby Hospital
Derby, DE22 3NE, United Kingdom
NCT Number: NCT03154593
Persistent swelling (chronic oedema), e.g. of the legs, is quite a common condition, which can cause a number of problems, including infections (cellulitis) in the swollen area and ulceration. It seems to be particularly common in people who are overweight but this has not been studied in detail. This study aims to address this gap in knowledge. It will take place in two stages, running in parallel to each other with different groups of patients. The first stage will determine how common persistent swelling is among patients attending weight management services at the Royal Derby Hospital and how it impacts on every day life. The second stage will determine whether weight loss surgery improves the swelling.
The results will inform future treatment guidelines for overweight patients who have swelling. They will also inform the design of future research that will investigate the effects of weight loss surgery in more detail, for example by testing out methods of measuring fluid changes in the legs.
All new patients attending the weight loss service will be eligible to take part in the first stage of the study, as long as they: give their informed consent to take part, and can speak English (or have someone with them who speaks English). Participants will not have had weight loss surgery previously. The Stage 1 assessment is expected to take about 40 minutes and consists of: a single clinical assessment for each participant to identify the presence of the swelling and its degree in each of the affected areas and, up to 3 questionnaires concerning their quality of life and mobility.
Patients attending the programme, who have been referred for bariatric surgery, will take part in the second stage of the study. Stage 2 will last approximately 13 months, during which time the participants will be assessed 4 times - once before surgery and at 3, 6, and 12-month intervals after surgery. Each Stage 2 assessment is expected to take about 50 minutes and consists of: a clinical assessment and up to 5 questionnaires.
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Notify Me18 year and older
All sexes
Observational
Derby, DE22 3NE, United Kingdom
The clinical assessments included in both stages of the study will identify the presence and severity of swelling in each of the affected areas. Each assessment will consist of a clinical examination of the patient's legs and abdomen to look for swelling and changes in the skin associated with this.
Assessments carried out in Stage 1 will include bioimpedance and tissue dielectric constant (TDC) techniques.
Assessments carried out in Stage 2 will include bioimpedance, TDC, and also perometry (or measuring using a tape measure).
None of the assessments included in either stage should cause any pain or discomfort.
The questionnaires, which will be completed in both stages, concern the participants' quality of life and mobility.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Stage 1 - all patients accepted for referral. There are no co-morbidities that would exclude people.
Stage 2 - patients that undergo bariatric surgery.
Exclusion criteria
Stage 2 - By-Band-Sleeve study participants who are taking part in the randomisation part of the study.
This observational study follows patients after routine bariatric surgery.
Time frame: 6 months
This will be achieved using: a clinical assessment to identify the presence or absence of chronic oedema.
Time frame: 6 months
This will be achieved using a clinical assessment to identify the degree of swelling in the affected areas.
Time frame: 6 months
This will be achieved using a range of quality of life questionnaires to identify the impact that the swelling has on the participants.
Time frame: Over 1 year, 6 months
This will be achieved by serial clinical assessment measures over a 12-month follow up after surgery.
Time frame: 6 months
The quality of life of participants with and without chronic oedema will be compared, using the scores from the quality of life questionnaires.
Time frame: 6 months
The bioimpedance data (measures total fluid within the legs) will be used to determine if the technique can define chronic oedema in this setting.
Time frame: 6 months
The tissue dielectric constant data (measures fluid levels at different points) will be used to determine if the technique can define chronic oedema in this setting.
Time frame: 6 months
The questionnaires will be used to collect data about the presence/severity of swelling of the patients. These will be important as they will help to determine the impact of chronic oedema on everyday life.
Time frame: Over 1 year, 6 months
The bioimpedance technique will be used to measure changes in the oedema from the baseline (pre-operative) measurement. The use of this technique will be validated by comparing the results with clinical assessment and limb volume measurements.
Time frame: Over 1 year, 6 months
The tissue dielectric constant technique will be used to measure changes in the oedema from the baseline (pre-operative) measurement. The use of this technique will be validated by comparing the results with clinical assessment and limb volume measurements.
Time frame: Over 1 year, 6 months
The clinical assessments [presence/severity of swelling and wounds (if present)] of the patients from their preoperative to their 12-month post-operative appointment will be compared in order to determine the impact of weight loss on chronic oedema. The effect sizes of these changes will be used to inform future study design and sample size calculation.
Time frame: Over 1 year, 6 months
The quality of life scores of the patients from their preoperative to their 12-month post-operative appointment will be compared in order to determine the impact of weight loss on chronic oedema. The effect sizes of these changes will be used to inform future study design and sample size calculation.
Time frame: Over 1 year, 6 months
Recruitment data (the percentage of eligible patients who consent to take part in the study, and the number withdrawing or not completing the study follow-up) will be used to inform sample size calculation for the future study.
University of Nottingham
Other
Prevalence and Impact of Chronic Oedema in a Population of Patients Prior to and Following Bariatric Surgery
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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